Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine (HSV-2)

• ClinicalTrials.gov Identifier: NCT02837575
• Recruitment Status: Completed
• First Posted: July 19, 2016
• Last Update Posted: February 27, 2019
• Sponsor: Vical
• Information provided by (Responsible Party): Vical

Tracking Information

• First Submitted Date: July 13, 2016
• First Posted Date: July 19, 2016
• Last Update Posted Date: February 27, 2019
• Study Start Date: September 2016
• Actual Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 26, 2016): Lesion recurrences [ Time Frame: Up to Day 450 ]
• Original Primary Outcome Measures (submitted: July 14, 2016): Lesion recurrences [ Time Frame: Up to Day 270 ]

Current Secondary Outcome Measures (submitted: September 26, 2016)

• Number of participants with adverse events [ Time Frame: Up to Day 450 ]
• Time to first recurrence [ Time Frame: Up to Day 450 ]
• Proportion of subjects recurrence-free [ Time Frame: Up to Day 450 ]

Original Secondary Outcome Measures (submitted: July 14, 2016)

• Number of participants with adverse events [ Time Frame: Up to Day 450 ]
• Proportion of subjects recurrence-free [ Time Frame: Up to Day 450 ]
• T-cell response change from base line for a subset of subjects as measured by interferon-gamma ELISPOT assay [ Time Frame: Baseline, Days 35, 63, 91, 180 and 450 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of Herpes Simplex Virus, Type 2 (HSV-2) Therapeutic DNA Vaccine in Adults With Symptomatic Genital HSV-2 Infection
• Brief Summary: The purpose of this trial is to evaluate the safety and efficacy of a therapeutic DNA vaccine in adults with symptomatic herpes simplex virus type 2 (i.e., genital herpes).
• Detailed Description: To evaluate the safety and efficacy of 4 doses of VCL-HB01, a therapeutic HSV plasmid DNA vaccine formulated with Vaxfectin® in HSV-2-seropositive adults with a reported history of symptomatic genital herpes for at least one year.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Herpes Genitalis

Intervention

• Biological: VCL-HB01
  Investigational Product
• Other: Phosphate-buffered saline
  Placebo
  Other Name: PBS

Study Arms

• Experimental: VCL-HB01, 1-mL dose
  VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 4 doses
  Intervention: Biological: VCL-HB01
• Placebo Comparator: Phosphate-buffered saline, 1-mL dose
  PBS, 1-mL dose by intramuscular injection once every 28 days for 4 doses
  Intervention: Other: Phosphate-buffered saline

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 27, 2017): 261
• Original Estimated Enrollment (submitted: July 14, 2016): 225
• Actual Study Completion Date: December 2018
• Actual Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• HSV-2 seropositive
• A minimum of 1 year of reported history of genital herpes with recurrences.

Exclusion Criteria:

• History of receiving an investigational HSV vaccine
• Chronic illness for which a subject's immune system is suspected to be impaired or altered, such as cancer, autoimmune conditions, or diabetes
• Pregnant or breastfeeding

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02837575
• Other Study ID Numbers: HSV2-201
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Vical
• Study Sponsor: Vical
• Collaborators: Not Provided

Investigators

• Study Director: Mammen P Mammen, MD, FIDSA; Vical

• PRS Account: Vical
• Verification Date: February 2019